FDA 510(k) Application Details - K000903

Device Classification Name Enzyme Immunoassay, Carbamazepine

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510(K) Number K000903
Device Name Enzyme Immunoassay, Carbamazepine
Applicant BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN, NY 10591-5097 US
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Contact FREDRICK CLERIE
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Regulation Number 862.3645

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Classification Product Code KLT
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Date Received 03/21/2000
Decision Date 05/18/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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